This invention pertains to devices useful for delivering medicaments to oral structures for a prolonged time. In particular, the device has a binder containing medicaments, the binder having adhesive properties and being disposed on a backing containing a plurality of microstructures.
Many methods are available to deliver medication or actives to a dental patient""s teeth and/or the gum tissues (i.e., gingiva). One method involves applying medication directly to teeth surface by use of a brush or swab. This method provides advantages such as relatively low expense and can be done by the patient. It has a major disadvantage, however, because the medication typically does not remain on the oral structures for a significant length of time. The medication contact time varies and may depend on factors such as the medication viscosity and the presence of saliva. Medication effectiveness can be reduced when it is removed prematurely from the oral structure intended for treatment.
Another method uses a delivery system containing a strip of material having medicaments, typically a tooth whitening substance, applied to the strip. In use, a user places the delivery system on teeth surface such that the whitening substance contacts the teeth surface. The substance can provide adhesive attachment between the strip of material and the teeth surface to hold the delivery system in place. Such delivery systems are disclosed in U.S. Pat. No. 5,879,691 (Sagel et al.); U.S. Pat. No. 5,891,453 (Sagel et al.); 5,894,017 (Sagel et al.); 5,989,569 (Dirksing et al.); 6,045,811 (Dirksing et al.); and WO 99/62472.
Yet another method involves placing a dental tray over the dental arch. The tray usually contains a channel that receives all or at least a portion of the teeth and optionally the gingiva. In some methods, the trays are custom-made to improve the fit to the patient""s dental arch. Such trays require preparation time but represent a significant improvement over mass-produced trays. The custom-made trays can be made by taking an alginate impression of the patient""s oral structure and then making a model from the impression. The trays may contain reservoirs for holding the medicaments. The trays may contain support members useful for resisting the flow of medication from the reservoir in at least one of a mesial-distal direction and a gingival direction. In this way, the dental tray maintains a high concentration of the medicaments to the desired oral structure for an extended period of time. Such dental trays are disclosed in publications WO 00/09036 and WO 00/44403.
While the various technologies discussed thus far provide useful methods for delivering medicaments to desired oral structures, other devices are sought.
The present invention provides a new device, typically in the form of a strip, capable of maintaining prolonged delivery of medicaments to oral structures, such as teeth and gums. As used herein, xe2x80x9cprolonged deliveryxe2x80x9d means that the binder and/or medicaments remain near the oral structure on the order of hours. Advantageously, the inventive device does not rely on the use of a dental tray and can be applied directly on the oral structure targeted for treatment.
In one aspect, the invention provides for a device delivering medicaments for treating oral structures, the device comprising or consisting essentially of (a) a flexible backing having a first surface containing a plurality of microstructures; and (b) a binder containing medicaments disposed on at least a portion of said first surface and/or at least a portion of said microstructures. In one embodiment, the binder is tacky so as to be able to bond adhesively to the target oral structures. In another aspect, the invention provides a kit containing the device and instructions for using it. As used herein, xe2x80x9coral structurexe2x80x9d means structures of or relating to the mouth, including teeth and soft tissues.
The invention also provides for various methods of delivering medicaments for treating oral structures. One illustrative method comprises or consists essentially of the following acts: (a) providing a flexible backing having a first and second surfaces, the first surface comprising a plurality of microstructures; (b) applying a binder containing medicaments to at least a portion of said first surface of the backing and/or to at least a portion of the microstructures to yield a precoated strip; then (c) applying the strip to oral structures such that the binder is proximal to the structures and the second surface of the backing lies near the buccal side. When binder lies in direct contact with the oral structure, the binder is tacky so that it can adhesively bond thereto. In an alternative method, the binder containing medicaments is first applied to the oral structures and a backing comprising microstructure elements is applied to the binder.
An advantage of the present invention is the use of microstructures on the backing. Without intending to be bound by theory, it is currently believed that the binder becomes interlocked with the microstructures. The microstructures, by virtue of their size, shape, and location, create barriers or obstacles to reduce the flow of the medicaments away from the target oral structure. The microstructures when disposed on the backing, also functions as a non-compressible space thereby allowing the medicament to be retained against the target oral structure. In this way, the oral structures are exposed to the medicaments for a longer period of time than compared to devices that do not use microstructures. This advantage translates in a reduction in the number of times a dental patient needs to change the device.
Another advantage of the present invention is that all the components can be formulated to be biodegradable, e.g., compatible with the user""s digestive system. This advantage could possibly lead to improved patient compliance to treatment. This advantage would be particularly useful for tooth bleaching applications.
Yet another advantage of the present invention is the ease of use to the consumer. The inventive product has been constructed so that it can be easily removed from a carrier and placed directly on the target oral structures without the need of using other dental devices, such as dental trays. It has also been constructed with various tabs to allow medicament delivery to the buccal and the lingual tooth surfaces. It is flexible and can be trimmed as necessary to fit the user""s mouth.